MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN ERGO II; FOR TREATMENT PURPOSES

Model Number MS9557

Device Problems Mechanical Problem (1384); Use of Device Problem (1670); Failure to Deliver (2338); Mechanical Jam (2983)

Patient Problems Hyperglycemia (1905); Coma (2417)

Event Type  Injury  

Manufacturer Narrative

If device is returned, evaluation will be performed to determine if a malfunction has occurred.This is an initial report.A follow-up report will be submitted when the final evaluation is completed.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: pending.This solicited case reported by a consumer via a patient support program (psp) concerned a (b)(6) (at the time of initial report) female patient of unknown origin.Medical history was not provided.Concomitant medication included insulin human for diabetes mellitus.The patient received human insulin (rdna origin) regular (humulin r) from cartridge via reusable pen device (humapen ergo ii), subcutaneously for the treatment of diabetes mellitus beginning on an unknown date approximately in 2019.Dosage regimen was not provided.On an unknown date after starting human insulin therapy, she suffered from fatigue so upon visiting her doctor he informed her to stop using it as and she does not need to take insulin anymore.On an unknown date when she stopped using it, she suffered from a diabetic coma and was admitted to the hospital.Her doctor switched her to insulin human (actrapid).On (b)(6) 2021, she started using actrapid in the ergo humapen.On an unknown date in (b)(6) 2021, the humapen got impaired as when she adjusted the dose and pressed to release insulin, the screw did not rotate and since then she was using insulin syringe (pc number: unknown; batch/lot number: 1710d04).On (b)(6) 2021, she was switched back to humulin r again.Outcome for the event of fatigue was recovered and was unknown for the event of diabetic coma.Information regarding the corrective treatment was unknown.Human insulin therapy was ongoing.The patient was the operator of the device and her training status was unknown.The general model device duration of use and the suspect device duration of use was 2 years.The suspect device status was not in use and if the device was returned, evaluation would be performed.The reporting consumer related the event of fatigue with the human insulin therapy whereas did not provide relatedness with the event of diabetic coma.No relatedness was provided between the events and the device.Edit 20 apr 2021: no new information added.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This solicited case reported by a consumer via a patient support program (psp) concerned a 20-year-old (at the time of initial report) female patient of unknown origin.Medical history was not provided.Concomitant medication included insulin human for diabetes mellitus.The patient received human insulin (rdna origin) regular (humulin r) from cartridge via reusable pen device (humapen ergo ii), subcutaneously for the treatment of diabetes mellitus beginning on an unknown date approximately in 2019.Dosage regimen was not provided.On an unknown date after starting human insulin therapy, she suffered from fatigue so upon visiting her doctor he informed her to stop using it as and she does not need to take insulin anymore.On an unknown date when she stopped using it, she suffered from a diabetic coma and was admitted to the hospital.Her doctor switched her to insulin human (actrapid).On (b)(6) 2021, she started using actrapid in the ergo humapen.On an unknown date in (b)(6) 2021, the humapen got impaired as when she adjusted the dose and pressed to release insulin, the screw did not rotate and since then she was using insulin syringe (pc number: unknown; batch/lot number: 1710d04).On (b)(6) 2021, she was switched back to humulin r again.Outcome for the event of fatigue was recovered and was unknown for the event of diabetic coma.Information regarding the corrective treatment was unknown.Human insulin therapy was ongoing.The patient was the operator of the device and her training status was unknown.The general model device duration of use and the suspect device suration of use was 2 years.The suspect device status was not in use and if the device was returned, evaluation would be performed.The reporting consumer related the event of fatigue with the human insulin therapy whereas did not provide relatedness with the event of diabetic coma.No relatedness was provided between the events and the device.Edit 20apr2021: updated medwatch fields for expedited device reporting.No new information added.Update 10may2021: additional information received on 10may2021 from the global product complaint database.Entered the device specific safety summary (dsss); updated the medwatch and european and canadian (eu/ca) device fields; and added the date of manufacture for the suspect device associated with (b)(4).Corresponding fields and narrative updated accordingly.

Manufacturer Narrative

B.5.Narrative field; new updated and corrected information is referenced within the update statements in b.5.Please refer to statement dated 10may2021 in the b.5.Field.No further follow up is planned.Evaluation summary: a female patient reported that, on an unknown date when on human insulin therapy, she suffered from fatigue and her doctor "informed her to stop using it as and she does not need to take insulin anymore." the patient experienced diabetic coma.On (b)(6) 2021, she started using a non-lilly insulin in a humapen ergo ii device.On an unknown date in (b)(6) 2021, the "device got impaired as when she adjusted the dose and pressed to release insulin, the screw did not rotate." the device was not returned to the manufacturer for investigation (batch 1710d04, manufactured october 2017).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A batch threshold review determined the total number of complaints received for the batch is within the established batch threshold and the batch is not atypical with regard to injection screw/ratchet not moving issues.All humapen ergo ii devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality with high probability.There is evidence of improper use.The patient used non-lilly insulin cartridge in the device.This misuse may be relevant to the complaint, but it is not likely relevant to the event of diabetic coma since the event occurred before the misuse.

• Brand Name: HUMAPEN ERGO II
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• MDR Report Key: 11724079
• MDR Text Key: 263463202
• Report Number: 1819470-2021-00053
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K151686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9557
• Device Lot Number: 1710D04
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 20 YR